A lupus drug that many experts predicted would probably not pan out has shown positive results in a late-stage clinical trial, researchers announced today. If approved by the Food and Drug Administration, the injectable drug, Benlysta, will be the first new therapy for systemic lupus erythematosus in 50 years.
This is from the Associated Press:
Biotech drugmaker Human Genome Sciences reported positive results Monday for its experimental drug to treat lupus, confounding analyst expectations and potentially clearing the way for the first new treatment against the inflammatory disease in a half century.
The late-stage results come after nearly a decade of research and development by the company aimed at relieving symptoms of lupus, a difficult-to-treat ailment in which the body attacks its own tissue and organs.
Patients who took the injectable drug Benlysta plus a standard treatment for one year had reduced symptoms — including pain, rashes and infections — compared with patients taking standard treatment plus placebo. The study involved more than 860 patients in Asia, South America and Eastern Europe. . .The Rockville, Md., company said 51.7 percent of patients taking 1 mg of Benlysta for every kilogram of body weight experienced a significant improvement. Of patients who took a larger dose, 10 mg per kilogram, 57.6 percent had a significant improvement. That compared with 43.6 percent for the placebo patients.
Following the results of a second study, the drug could become available in 2010. Advocacy organizations praised the news.
“We are very hopeful that we now are strongly on our way to the first new treatment for lupus in 50 years,” said Margaret G. Dowd, president of the Lupus Research Institute, in a news release. “We look forward to the impact that a new drug for lupus will have on the lives of the 1.5 million Americans, and millions more worldwide, who suffer from this devastating autoimmune illness."
“This is the first drug shown to be effective in ameliorating the signs and symptoms of lupus in decades,” said Dr. Daniel J. Wallace, clinical professor of medicine at the David Geffen School of Medicine at UCLA. “It represents a breakthrough for finally utilizing a methodology that enables researchers to demonstrate disease improvement. This will benefit lupus patients and their doctors.”
-- Shari Roan